MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN RF ELECTRODE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hemothorax (1896); Shock (2072); Intra-Abdominal Hemorrhage (4479); Unspecified Hepatic or Biliary Problem (4493); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2021

Event Type  Death  

Manufacturer Narrative

Title: radiofrequency ablation of liver tumors in patients on antithrombotic therapy: a case-control analysis of over 10,000 treatments source: j vasc interv radiol 2021; 32:869¿877.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study reported on the safety of a radiofrequency ablation for liver tumors for patients receiving antithrombotic therapy.Between february 1999 to december 2018, 3485 patients underwent rfa for liver tumors.Because 2,227 patients underwent repeated rfa because of recurrence, the total number of tumor treatments was 10,653 performed over 15,009 sessions.Among the 10,653 treatments, hemorrhagic complications were diagnosed after 54 treatments.Hemoperitoneum was diagnosed in 26 patients and of these, two patients underwent transcatheter arterial embolization (tae) for hemoperitoneum.Hemothorax occurred in 21 patients with 20 of these requiring chest drainage, 3 patients undergoing tae.Overall, death related to hemorrhagic complications occurred in 3 patients (2 experienced hemothorax, and 1 experienced hemoperitoneum).In all 3 cases, hemorrhagic complications were diagnosed during the hospitalization, and tae was performed to stop the bleeding.Although hemorrhage was stopped, the patients died because of multiple organ failure after hemorrhagic shock despite intensive care.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN RF ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12579622
• MDR Text Key: 274900094
• Report Number: 1717344-2021-01357
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN RF ELECTRODE
• Device Catalogue Number: UNKNOWN RF ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death